On May 23, 2024 I-Mab (the "Company") (NASDAQ: IMAB) a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, reported that Gerald Falchook, MD, and the team at I-Mab’s partner for ragistomig (or "ABL503"), ABL Bio (KOSDAQ: 298380), will present a poster related to Phase 1 data for ragistomig at the 2024 American Society for Clinical Oncology Annual Meeting ("ASCO 2024"), taking place from May 31st to June 4th at the McCormick Place Convention Center in Chicago, IL (Press release, I-Mab Biopharma, MAY 23, 2024, View Source [SID1234643603]).

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Ragistomig was designed as a bispecific antibody to provide anti-PD-L1 activity and 4-1BB-driven T-cell activation in one molecule. The combination of an Fc-silent and conditional 4-1BB engagement was intended to optimize the compound for safety, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonists.

The first-in-human Phase 1 study was designed to define the dose-limiting toxicity and safety profile of ragistomig monotherapy (primary endpoints) as well as to observe the objective response rate (ORR), pharmacokinetic (PK) and immunogenicity profiles (secondary endpoints). The study is being conducted in patients with advanced or relapsed/refractory solid tumors and the majority of patients (56.6%) received prior anti-PD(L)-1 immunotherapy. The main observations from the study include:

· A manageable safety profile;

· Definition of an optimal dose of 5 mg/kg, with dose proportional pharmacokinetics (PK);

· Overall response rate of 25% at 5 mg/kg, based on 3 partial responses (PR) out of 12 patients with median progression free survival (PFS) of 15.6 weeks;

· Clinical benefit rate of 75% at 5 mg/kg, based on 3 PRs and 6 stable disease (SD);

· 71.4% of responders had received prior anti-PD-(L1) inhibitors and were all relapsed or refractory to anti-PD-(L1) inhibitors; and

· A complete response (CR) was seen in one heavily pretreated patient (7 prior lines of therapy, ovarian cancer) at 3 mg/kg.

"We are pleased to present the Phase 1 data to date for ragistomig at ASCO (Free ASCO Whitepaper) 2024. While immune checkpoint inhibitors have made a significant contribution to the treatment of solid tumor cancers, many tumors do not respond or become refractory to these agents. Ragistomig was designed to provide a new treatment option for patients who are resistant to immune checkpoint inhibitors," said Raj Kannan, Chief Executive Officer at I-Mab. "Topline data indicate that the study met its objectives, enabling the definition of an optimal dose, and provided several early efficacy observations in patients relapsed or refractory to prior checkpoint inhibitor treatment. These data support further development of ragistomig as both a monotherapy and in combination with other compounds. We look forward to advancing the clinical program in collaboration with our partner, ABL Bio."

Louie Naumovski, MD, PhD, Interim Chief Medical Officer for I-Mab commented, "We are pleased by ragistomig’s manageable safety, T-cell activation profile and dose proportional pharmacokinetics. Observation of responses is also encouraging, including a 25% ORR and a 75% clinical benefit rate (CBR), at the optimal dose of 5 mg/kg. Notably, the majority of patients were heavily pretreated, with three or more lines of therapy, including a prior PD-(L)1 inhibitor, and the majority of responders (71.4%) had received prior anti-PD-(L)1 therapy. Together, these data provide sound support to continue the development of ragistomig, with ongoing follow-up of this initial Phase 1 study."

The data will be reported in a poster entitled "Phase 1 trial Safety and Efficacy of Ragistomig, a Bispecific Antibody Targeting PD-L1 and 4-1BB in Advanced Solid Tumors" (Abstract #2529, Poster Board 8), at ASCO (Free ASCO Whitepaper) 2024 on June 1, 2024 from 9:00 a.m. – 12:00 p.m. C.D.T. in the Developmental Therapeutics – Immunotherapy session by Dr. Gerald Falchook, MD, Director of the Sarah Cannon Research Institute at HealthONE, a clinical trials program in Denver, Colorado, for patients with advanced cancer.

About Ragistomig

Being developed jointly with ABL Bio, ragistomig (also known as ABL503) is a differentiated PD-L1-based bispecific antibody that fuses an Fc-silent anti-PD-L1 arm, as the tumor-dependent T-cell activator, with a single chain variable fragment of an anti-4-1BB engaging antibody, as the conditional T-cell activator, upon tumor engagement. Using ABL Bio’s "Grabody-T" bispecific antibody platform technology, ragistomig/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity and overcome resistance to PD-(L)1 inhibition. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. A Phase 1 dose escalation and dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed to define the dose-limiting toxicity and adverse event profile of ragistomig (primary endpoints) as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles (secondary endpoints).

On May 23, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported positive updated results from its Phase 1/2 clinical trial of HB-200 for the treatment of human papillomavirus 16 positive (HPV16+) head and neck cancers (Press release, Hookipa Biotech, MAY 23, 2024, View Source [SID1234643601]). The data were published in the Company’s abstract for the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting and support the Company’s pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab in the first line setting.

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The abstract reported data as of January 12, 2024, and included 42 patients treated with HB-200 plus pembrolizumab. The treatment was generally well tolerated with a low rate of treatment-related discontinuation and no treatment-related deaths.

Among a subpopulation of 17 evaluable patients with CPS of 20 or higher, the updated data showed confirmed ORR of 53 percent, CR rate of 18 percent, and DCR of 82 percent. This subpopulation is representative of patients eligible for the Company’s pivotal Phase 2/3 trial, which will begin enrolling patients in the fourth quarter of 2024.

Additional data will be presented in the Head and Neck Oral Abstract Session at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting on June 4, at 11:09 a.m. CDT. During the presentation, preliminary progression-free survival and overall survival data will be shared for the first time.

"We are happy to provide an update on our clinical data and showcase the meaningful outcomes we are helping to drive for patients," said Joern Aldag, Chief Executive Officer of HOOKIPA. "The data exhibit strong evidence that has helped inform our pivotal Phase 2/3 trial design, which will begin enrolling patients later this year. This update gives us conviction that we are on the right path to achieve our goals and help provide a new targeted therapeutic option for patients battling HPV16+ head and neck cancer."

Results:
HB-200 in combination with pembrolizumab:
The abstract presented data as of January 12, 2024, and included 42 first line patients with HPV16+, PD-L1 positive, recurrent or metastatic head and neck squamous cell carcinoma. The updated data continue to demonstrate a favorable safety profile of HB-200 in combination with pembrolizumab and promising clinical activity as a first line treatment. Median follow-up time was 5.6 months.

HB-200 + pembrolizumab were generally well tolerated. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 6 (14%) patients, serious TRAEs were reported in 3 (7%) patients, and TRAEs leading to treatment discontinuation were reported in 2 (5%) patients. No treatment-related deaths were reported.

Among 35 evaluable patients—those with ≥ 1 post-baseline tumor response assessment—3 confirmed complete responses, 9 confirmed partial responses, and 3 unconfirmed partial responses were observed. Notably, among patients with PD-L1 CPS ≥20 (N=17), ORR, based on confirmed responses, was 53%, CR rate was 18%, and DCR was 82%.

Additional Abstracts at ASCO (Free ASCO Whitepaper) 2024 Annual Meeting:
HB-200 plus chemotherapy (neoadjuvant setting):
In addition, data from an Investigator Initiated Trial (IIT), led by Dr. Ari Rosenberg of the University of Chicago Department of Medicine, will be presented on June 3, in the Head and Neck Rapid Oral Abstract Session. The study concluded that neoadjuvant HB-200 plus chemotherapy for the treatment of patients with non-metastatic HPV16+ oropharyngeal cancers (OPC) is safe and feasible, with early efficacy signal in this setting warranting further study.

Twenty-one patients with HPV16+ OPC were enrolled and treated across multiple cohorts and dose levels. All patients completed neoadjuvant HB-200/chemotherapy and response-stratified locoregional treatment. Deep responses following HB-200/chemotherapy were observed in 17/21 (81%) patients, and in 14/15 (93%) patients treated with higher dose levels 1 or 2. All three patients who underwent transoral robotic surgery (TORS) had no viable tumor at time of surgery. Two patients (9%) had persistent disease following chemoradiotherapy and underwent salvage surgery with no evidence of disease at last follow-up. ctHPV-DNA and HPV16-specific T-cell response data will be presented at the meeting.

Enrollment to the subsequent randomized phase II part is ongoing. Details of the rapid oral presentation are included below.

HB-700 preclinical data:
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations (G12D, G12V, G12R, G12C and G13D) and has the potential to benefit a broader patient population than single mutation inhibitors.

A transgene cassette consisting of peptide stretches including KRAS mutations G12D, G12V, G12C, G12R and G13D was generated by in silico aided antigen design. KRAS mutation specific CD8+ T cell expansion was evaluated in HLA transgenic mice treated with HB-700 and functionality of induced CD8+ T cells was evaluated by assessing CD8+ T cell mediated killing of mutant KRAS peptide loaded target cells in vivo.

All treatment regimens were well tolerated, and no mortalities or major adverse events were observed. The results indicate efficient induction of KRAS mutation specific T cell responses in HLA transgenic mice. Expanded CD8+ T cells were capable of killing cells loaded with KRAS mutation specific peptides in vivo indicating functionality of the induced T cell responses. No specific cytotoxicity towards target cells pulsed with KRAS wild type peptides was observed in any of the groups. HOOKIPA’s HB-700 investigational product candidate differs from KRAS inhibitors and has a wide range of combinability options including with small-molecule inhibitors. Based on these results, initiation of a Phase I study for the treatment of KRAS mutated cancers is planned.

Abstract details: ASCO (Free ASCO Whitepaper) 2024 Annual Meeting

HB-200:
Title: HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results
Presenter: Dr. Alan L. Ho, Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator
Abstract Type: Oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 4, 2024; 9:45 AM-12:45 PM CDT
Abstract Number: 6005

Investigator Initiated Trial:
Title: Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV
Presenter: Dr. Ari Rosenberg, Principal Investigator, TARGET-HPV Trial, University of Chicago Medicine
Abstract Type: Rapid oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 3, 2024; 8:00 AM-9:30 AM CDT
Abstract Number: 6017
Trial Sponsor: UChicago Medicine

HB-700
Title: Development of an arenavirus-based immunotherapy for treatment of KRAS mutant cancer
Abstract Type: Abstract only
Session Date: May 23, 2024
Abstract Number: e14672

About HB-200
HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus (LCMV) and pichinde virus (PICV). Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen.

HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma. These designations are supported by preliminary clinical evidence from the Phase 1/2, open-label, clinical trial (NCT04180215) evaluating safety, T cell response, and efficacy based on objective response rate (ORR) and disease control rate (DCR) as defined by RECIST 1.1. and iRECIST.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations (G12D, G12V, G12R, G12C and G13D) and has the potential to benefit a broader patient population than single mutation inhibitors.

On May 23, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), reported that its management team will be participating and presenting on its proprietary ADC technology platforms at the following scientific conferences in May and June in 2024 (Press release, Heidelberg Pharma, MAY 23, 2024, View Source [SID1234643599]).

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Heidelberg Pharma is an ADC specialist, developing innovative drugs based on its proprietary ADC toolbox for the targeted and highly effective treatment of cancer. Its lead Amanitin-based ADC product candidate, HDP-101, targeting relapsed or refractory multiple myeloma has recently received Orphan Drug Designation (ODD) and is currently advancing in a Phase I/IIa clinical trial, demonstrating first signs of clinical efficacy. The Company is also rapidly expanding its therapeutic product pipeline with a further four programs across a variety of malignant hematologic and solid tumors.

10th Annual Oncology Innovation Forum

Date & location: 31 May 2024, Chicago, Illinois, USA

Panel: Investing in NextGen ADCs

Date: 31 May, 10:45 am CDT

Panellist: Professor Andreas Pahl, Chief Executive Officer

Presentation title: Company presentation

Date: 31 May, 02:00 pm CDT

Presenter: Professor Andreas Pahl, Chief Executive Officer

Professor Pahl will be available for one-on-one meetings, which can be arranged via the online conference system.

ASCO Annual Meeting

Date & location: 31 May–4 June 2024, Chicago, Illinois, USA

Attending: Professor Andreas Pahl, Chief Executive Officer & Dr. András Strassz, Chief Medical Officer

Professor Pahl and Dr. Strassz will be available for meetings.

BIO International Convention

Date & location: 3–6 June 2024, San Diego, California, USA

Attending: Dr. George Badescu, Chief Business Officer & Dr. Artjom Wischnjow, Associate Director Business Development

Dr. Badescu and Dr. Wischnjow will be available for one-on-one meetings, which can be arranged via the online conference system.

Jefferies Global Healthcare Conference

Date & location: 4–6 June 2024, New York, USA

Attending: Professor Andreas Pahl, Chief Executive Officer & Dr. George Badescu, Chief Business Officer

Professor Pahl and Dr. Badescu will be available for one-on-one meetings, which can be arranged via the online conference system.

On May 23, 2024 Grey Wolf Therapeutics ("Grey Wolf" or "the company"), a clinical-stage biotechnology company leveraging first-of-its-kind antigen modulation therapies to address the source of immune dysfunction in oncology and autoimmunity, reported the closing of an oversubscribed $50 million Series B financing expansion, bringing the total amount of Series B funds raised to $99 million (Press release, Grey Wolf Therapeutics, MAY 23, 2024, View Source [SID1234643598]). The Series B expansion round was led by ICG’s Life Sciences team and included further investment from existing investors Pfizer Ventures, Andera Partners, Canaan, Earlybird Venture Capital, Oxford Science Enterprises and British Patient Capital. Proceeds from the round will be leveraged to broaden the scope of the company’s ongoing Phase 1/2 clinical trial of its lead immuno-oncology candidate, GRWD5769, in a range of solid tumour types. The funding also enables the company to expand research and development (R&D) for its versatile antigen modulation approach into treatments for autoimmune disease indications.

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"The funds raised as part of this Series B expansion round allows us to enrich our ongoing clinical trial of GRWD5769 to include patients with a wider variety of tumour types and evaluate new combination treatment cohorts. In addition, the new capital enables us to more fully explore the breadth of potential therapeutic applications for our antigen modulation technology," said Peter Joyce, Ph.D., chief executive officer of Grey Wolf Therapeutics. "There is a wealth of supportive recent clinical research and compelling human genetic associations pointing to the potential for antigen modulation driven by ERAP inhibition to open the door for disease-modifying therapies in the field of autoimmune disease. As such, we are expanding our R&D efforts and evaluating these broader therapeutic applications for our unique technology."

Initial data on the ongoing adaptive Phase 1/2 trial of the lead asset GRWD5769, a first-in-class ERAP1 inhibitor will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. A second ERAP1 inhibitor focussed on autoimmune disease is being advanced through IND-enabling studies with the goal of entering the clinic in 2025.

Tracy Weightman, Associate Director, Life Sciences at ICG, added, "Grey Wolf is an exciting growth stage UK biotechnology company with a novel and differentiated approach that has the potential to transform the lives of millions of patients globally. This investment demonstrates our commitment to building leading biotechnology companies and enabling them to compete on a global stage. We are pleased to support Grey Wolf through the next stage of its growth journey, enabling the company to advance its clinical development strategy and expand into new therapeutic areas."

In conjunction with the financing, Grey Wolf has announced that Ms. Weightman has been appointed to the company’s board of directors.

About ERAP Inhibition

Grey Wolf has developed and is advancing a unique therapeutic strategy that leverages the ability to effectively modulate the presentation of target antigens to the human immune system to upregulate or downregulate immune cell activity for specific therapeutic outcomes. This is achieved through the targeted inhibition of the endoplasmic reticulum aminopeptidases (ERAP1 or ERAP2), proteins that play a key role in the antigen presentation pathway. In cancer, inhibiting ERAP1 or ERAP2 drives the generation and presentation of novel and potent antigens to elicit targeted immune activity. Additionally, this mechanism works to block the production of disease-causing auto-antigens to prevent pathogenic immune responses that drive autoimmune diseases.

On May 23, 2024 GSK plc (LSE/NYSE: GSK) reported that findings across its oncology portfolio will be presented in 25 abstracts at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (31 May – 4 June) in Chicago, IL (Press release, GlaxoSmithKline, MAY 23, 2024, View Source [SID1234643597]). The presentations support GSK’s ongoing focus and commitment to advance care in blood cancers, gynaecologic cancers and certain solid tumours through novel approaches.

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DREAMM programme updates
Pivotal data will be shared from the DREAMM-8 and DREAMM-7 phase III trials showing the potential of belantamab mafodotin in combination versus standard of care in multiple myeloma at or after first relapse, including:

Results from the DREAMM-8 trial evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone (PomDex) versus bortezomib combined with PomDex. This data was selected for inclusion in ASCO (Free ASCO Whitepaper) press programme (ASCO abstract #LBA105).
Subgroup analyses from the DREAMM-7 trial evaluating belantamab mafodotin plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex (ASCO abstract #7503).
Encore presentation (ASCO abstract #7543) of the primary results from DREAMM-7, originally featured in the ASCO (Free ASCO Whitepaper) Plenary Series on 6 February 2024.
Collaborations to improve patient care
Encouraging new data will be presented from GSK’s portfolio of supported collaborative studies and alliances that could transform outcomes for patients with cancer:

Updated results for dostarlimab in locally advanced mismatch repair deficient (dMMR) rectal cancer will be presented in a late-breaking rapid oral presentation (ASCO abstract #LBA3512), a supported collaborative study with Memorial Sloan Kettering Cancer Center. This follows data presented at the 2022 ASCO (Free ASCO Whitepaper) and 2023 Japanese Society of Medical Oncology Annual Meetings.
Hansoh Pharma will deliver an oral presentation on their phase II study of HS-20093 in Chinese patients with relapsed or refractory osteosarcoma (ASCO abstract #11507). Earlier this year, GSK obtained exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau and Taiwan) to progress clinical development and commercialisation of HS-20093.
Updated results will be presented from a phase 0/II trial of niraparib in patients with newly diagnosed MGMT-unmethylated glioblastoma (ASCO abstract #2002), a supported collaborative study sponsored by the Ivy Brain Tumor Center. Treatment with niraparib achieved a median overall survival of 20.3 months, compared to a historical control of 12.7 months.1,2. The safety profile was consistent with what has been previously reported in this study. Based on these results, a phase III clinical trial of niraparib versus standard of care has been accelerated, supported by GSK.
Full list of GSK’s presentations at ASCO (Free ASCO Whitepaper):
Belantamab Mafodotin

Abstract Name Presenter Presentation Details
Results from the randomized Phase III DREAMM-8 study of belantamab mafodotin (belamaf) plus pomalidomide and dexamethasone (BPd) versus pomalidomide plus bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM)

S. Trudel

Clinical Science Symposium,

#LBA105

Results from the randomized phase III DREAMM-7 study of belamaf + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM)

MV. Mateos

Oral, Education session,

Presentation 4

DREAMM-7 update: Subgroup analyses from a Phase III trial of belamaf + bortezomib and dexamethasone (BVd) vs daratumumab, bortezomib and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM)

MV. Mateos

Oral abstract session,

#7503

Patient-reported outcomes (PRO) from the DREAMM-7 randomized phase 3 study comparing belamaf, bortezomib, dexamethasone (BVd) vs daratumumab, bortezomib and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM)

V. Hungria

Poster session,

#7543

Dostarlimab

Abstract Name Presenter Presentation Details
Post hoc analysis of progression-free survival (PFS) and overall survival (OS) by mechanism of mismatch repair (MMR) protein loss in patients with endometrial cancer treated with dostarlimab plus chemotherapy in the RUBY trial

M. Mirza

Poster session,

#5606

Time course of adverse events in primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy in the ENGOT-EN-6-NSGO/GOG-3031/RUBY trial

E. Lokich

Poster session,

#5607

Niraparib

Abstract Name Presenter Presentation Details
The BEV1L study: Do real-world outcomes associated with the addition of bevacizumab to first-line chemotherapy in patients with ovarian cancer reinforce clinical trial findings?

L. Duska

Poster session,

#5563

First-in-human, phase 1/2 study of GSK4524101, an oral DNA polymerase theta inhibitor (POLQi), alone or combined with the poly(ADP-ribose) polymerase (PARP) inhibitor (PARPi) niraparib in adults with solid tumors

V. Samnotra

Poster session,

#TPS3174

Momelotinib

Abstract Name Presenter Presentation Details
Long-term survival adjusted for treatment crossover in patients (pts) with myelofibrosis (MF) treated with momelotinib (MMB) vs. danazol (DAN) in the MOMENTUM trial

R. Mesa

Poster session,

#6571

Association between hemoglobin (Hb) improvement and patient-reported outcomes (PROs) in patients (pts) with myelofibrosis (MF) patients and anemia: Post hoc pooled analysis of momelotinib (MMB) phase 3 trials

T. LeBlanc

Poster session,

#6574

Patient (pt) interview–based content validation of the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)

A. Cardellino

Online publication,

#e23106

Patient (pt) experience with and perceptions around transfusion-dependent (TD) and transfusion-independent (TI) myelofibrosis (MF): A qualitative interview study

A. Cardellino

Online publication,

#e23110

Cobolimab

Abstract Name Presenter Presentation Details
Real-world treatment patterns and outcomes in US patients (pts) with advanced non-small cell lung cancer (NSCLC) after platinum-based chemotherapy (PBC) and anti–PD-(L)1 treatment

V. Velcheti

Poster session,

#8627

Full list of investigator-initiated studies and supported collaborative studies at ASCO (Free ASCO Whitepaper):

Abstract Name Presenter Presentation Details
Durable complete responses to PD-1 blockade alone in locally advanced mismatch repair deficient locally advanced rectal cancer

A. Cercek

Rapid oral abstract session,

#LBA3512

Niraparib and dostarlimab efficacy in patients with platinum-sensitive relapsed mesothelioma: MIST5, a phase IIa clinical trial

DA. Fennell

Rapid oral abstract session,

#8017

Niraparib efficacy in patients with newly-diagnosed glioblastoma: Clinical readout of a phase 0/2 "trigger" trial

N. Sanai

Oral abstract session,

#2002

Evaluation of a novel method to guide belantamab mafodotin dosing in multiple myeloma based on a patient-reported questionnaire

E. Terpos

Poster presentation,

#7530

Open-label, single-arm phase Ib/II study of immune combination therapy with elotuzumab and belantamab mafodotin in patients with with relapsed/refractory multiple myeloma

N. Neparidze

Poster presentation,

#7559

A three-arm randomized phase II study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma: DOVE (APGOT-OV7/ENGOT-ov80 study)

JY. Lee

Poster session,

#TPS5627

TTCC-2022-01: Niraparib and dostarlimab in locally-advanced head and neck squamous cell carcinoma treated with (chemo) radiotherapy (RADIAN)

M. Oliva

Poster session,

#TPS6125

Efficacy and safety of GPRC5D-based monotherapies for relapsed/refractory multiple myeloma: A systematic review and meta-analysis

A. Shrestha

Online publication,

#e19503

Real-world analysis of belantamab mafodotin (belamaf): care patterns in relapsed/refractory multiple myeloma

M. Patel

Online publication,

#e19507

Age-related differences in information seeking behaviors of patients with multiple myeloma

JM. Ahlstrom

Online publication,

#e19523

Exploring gender-based decision-making differences among patients with relapsed/refractory multiple myeloma

M. Arnett

Online publication,

#e19524

The role of patient-driven education in decision-making for relapsed/refractory multiple myeloma

JR. Hydren

Online publication,

#e19532

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.3,4 There are approximately 176,000 new cases of multiple myeloma diagnosed globally each year.5 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.6

About dMMR/MSI-H rectal cancer
Rectal cancer is a form of cancer that starts in the rectum, the final section of the large intestine, and is often categorised as part of a group of cancers called colorectal cancer.7 Colorectal cancer is the third most commonly diagnosed cancer in the world.8 In the US, it is estimated that approximately 46,220 individuals are diagnosed annually with rectal cancer.9 Approximately 5-10% of all rectal cancers are dMMR/microsatellite instability-high (MSI-H), meaning that they contain abnormalities that affect the proper repair of DNA when copied in a cell.10 Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy.11,12 Tumours with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers but may also be found in other solid tumours.13-15

About glioblastoma
Glioblastoma is a type of cancer that starts as a growth of cells in the brain or spinal cord. It grows quickly and can invade and destroy healthy tissue.16 It accounts for more than half of all primary malignant brain tumours and is one of the most complex and treatment-resistant cancers, resulting in poor patient outcomes.17 Survival rates and mortality statistics for glioblastoma have been virtually unchanged for decades, highlighting the need to investigate new treatment options.17

About belantamab mafodotin
Belantamab mafodotin is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Important information for Blenrep in Great Britain (GB)
Indication
Blenrep is indicated (GB):
as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD39 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Refer to the Blenrep UK Summary of Product Characteristics18 for a full list of adverse events and the complete important safety information in the United Kingdom.

About Jemperli (dostarlimab)
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.19

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a US FDA-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The supplemental Biologics License Application supporting the newly approved indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the US FDA.

Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.

Important Information for Jemperli in the EU
Indication
Jemperli is indicated:
in combination with carboplatin-paclitaxel, for the treatment of adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy;
as monotherapy for treating adult patients with mismatch repair deficient dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

About Zejula (niraparib)
Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; and for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula.

Important Information for Zejula in the EU
Indication 
Zejula is indicated:
as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Refer to the Zejula EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

About Omjjara (momelotinib)
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).20,21, 22, 23 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.21, 23, 25 Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.21,22,23, 24

In September 2023, the US Food and Drug Administration licensed momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia.

In January 2024, the European Commission granted marketing authorisation for Omjjara for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. Omjjara was also approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia.

Important Information for Omjjara in the EU
Indication
Omjjara is indicated:
for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Refer to the Omjjara EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.